510(k) K140163 ยท HFM Monitor, Uterine Contraction, External (For Use In Clinic)
KOALA TOCO
| Applicant | Clinical Innovations, LLC, Marlborough MA, US |
| Decision | Substantially Equivalent, May 29, 2014 |
| Received | Jan 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140163
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.